Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec

NCT03938740 | Completed Phase 2 FDA Drug

• 1 other identifier: DP 01-2019-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 7

Brief Summary

Multi-center, open-label, multiple dose safety, tolerability and efficacy study

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period

  Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period

  24 weeks

• Basal/bolus ratios during the last 2 weeks of the treatment period

  Basal/bolus ratios during the last 2 weeks of the treatment period

  24 weeks

Study Arms (2)

HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%

EXPERIMENTAL

HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%

Drug: HDV-Insulin Lispro and Insulin Degludec (-40%)

HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%

EXPERIMENTAL

HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%

Drug: HDV-Insulin Lispro and Insulin Degludec (-10%)

Interventions

HDV-Insulin Lispro and Insulin Degludec (-40%) DRUG

HDV-Insulin Lispro and Insulin Degludec (-40%)

HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%

HDV-Insulin Lispro and Insulin Degludec (-10%) DRUG

HDV-Insulin Lispro and Insulin Degludec (-10%)

HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of age 18 to 65 years, inclusive.
• If female of child-bearing potential, must agree for the duration of the study. to use adequate contraceptive measures, such as, intra-uterine device \[IUD\], oral or injectable contraceptives, or barrier method plus spermicide.
• Has at Screening been diagnosed as T1DM for at least 12 months.
• Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed).
• Has at Screening been on treatment with rapid analog insulin for the previous six (6) months.
• Has at Screening willingness to use continuous glucose monitoring (CGM) technology throughout study.
• Is, for the duration of the study, willing to use insulin lispro as the only analog bolus insulin and insulin degludec as the only basal insulin.
• Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2.
• Has at Screening HbA1c ≥6.5% and ≤8.5%.

You may not qualify if:

• Has known or suspected allergy to any component of any of the study drugs in this trial.
• Is, at Screening, pregnant or breast-feeding, or intends to become pregnant at any time during the duration of the study.
• Has, at Screening, as judged by the Site Investigator, a history or current evidence of any of the following complications of diabetes: proliferative retinopathy or maculopathy, severe neuropathy (in particular, autonomic neuropathy), symptomatic gastroparesis.
• Is, at Screening, judged by the Site Investigator to have a current addiction to alcohol or substances of abuse.
• Is, at Screening, using one or more drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia (e.g., beta blockers, systemic corticosteroids at pharmacologic doses, cancer chemotherapies.).
• Has at Screening any of the following findings, unless approved by both the Site Investigator and the Medical Monitor:
• Uncontrolled hypertension, defined as diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the sitting position;
• History of or findings on EKG of cardiac arrhythmia or conduction defect;
• Clinically significant abnormalities on Screening laboratory studies
• Has, within one (1) month prior to Screening, used either oral anti-diabetic medication or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.).
• Has, within one (1) month prior to Screening, received any investigational drug.
• Has, within two (2) months prior to Screening, used an insulin pump delivery system.
• Has, within three (3) months prior to Screening, smoked tobacco or used any smokeless tobacco or nicotine delivery system (inhaled, oral or buccal).
• Has at Screening, as judged by the Site Investigator, any condition (intrinsic or extrinsic) that could reasonably be expected to interfere with trial participation, confound evaluation of the data, or pose additional risk to adhering to the study protocol. Examples of such conditions include but are not limited to:
• Clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems;

Sponsors & Collaborators

• Diasome Pharmaceuticals: lead

Study Sites (7)

Mills-Peninsula Medical Center, Diabetes Research Institute

San Mateo, California, 94401, United States

Location

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

Location

Texas Diabetes & Endocrinology, PA

Austin, Texas, 78749, United States

Location

Texas Diabetes & Endocrinology, PA

Round Rock, Texas, 78681, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Penn, MD, PhD

  Diasome Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 6, 2019
• Study Start: March 18, 2019
• Primary Completion: December 6, 2019
• Study Completion: March 18, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)